The Effect of Pre-sacral Nerve Block on Immediate Post-operative Pain Following Laparoscopic Hysterectomy.

NCT03646006 | Unknown Phase 4

• 1 other identifier: MSH REB 16-0203-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hysterectomy (removal of the uterus) is the most common major gynecologic surgery performed in Canada. With a focus on minimally invasive techniques and optimization of peri-operative pain control, gynaecologists have made great strides towards reducing hospital stay and accelerating post-operative recovery. These are essential achievements, both for patients and their families and for our resource-limited public healthcare system. Optimization of peri-operative pain control is multifactorial and includes, for example, administration of pre-operative analgesics, infiltration of incision sites with local anesthetic and provision of post-operative pain medications. As the understanding of pain mechanisms evolves, the incorporation of intra-operative nerve blocks has become yet another effective strategy to reduce post-operative pain. The presacral nerve plexus, which carries nerve fibers from the uterus to the brain, is an important pathway that transmits midline pelvic pain in women. Destruction of the pre-sacral nerves has been shown to provide excellent pain control in a variety of clinical settings. While transection of the presacral nerve at the time of surgery is technically challenging, instilling a presacral nerve block is surprisingly straightforward making this technique safe to perform in the hands of many gynecologists. In this technique, local anesthetic is instilled into the presacral space using a needle inserted through the abdomen. Given that the presacral nerve plexus is an integral pain pathway for the uterus, the investigators hypothesize that the addition of a presacral nerve block during laparoscopic (camera surgery) hysterectomy would confer an additional reduction in immediate post-operative pain. The proposed study therefore aims to look at the impact of presacral nerve block versus a sham (blank) block on immediate post-operative pain in a group of women scheduled to undergo laparoscopic hysterectomy.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Post-operative pain at 3 hours

  Pain measured on a visual analogue scale (VAS). Range will be from zero (no pain) to 10 (most pain).

  3 hours post-operatively

Secondary Outcomes (5)

• Post-operative pain at 1 hour

  1 hour post-operatively

• Post-operative pain at 2 hours

  2 hours post-operatively

• Post-operative narcotic consumption

  On day of surgery

• Post-operative anti-emetic consumption

  On day of surgery

• Adverse Events

  6 weeks following surgery

Other Outcomes (5)

• Estimated blood loss

  On day of surgery

• Operative Time

  On day of surgery

• Time to first ambulation

  On day of surgery

Study Arms (2)

Pre-sacral nerve block

EXPERIMENTAL

10 mL bupivacaine (5mg/mL)

Drug: Bupivacaine

Sham block

SHAM COMPARATOR

10 mL normal saline

Drug: Placebo

Interventions

Bupivacaine DRUG

10 mL (5mg/mL)

Pre-sacral nerve block

Placebo DRUG

10 mL normal saline

Sham block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing elective total laparoscopic hysterectomy
• Age \> 18 years

You may not qualify if:

• Previous presacral neurectomy
• Concurrent surgical procedure other than salpingectomy and/or oophorectomy
• Gynecological cancer beyond stage 1 disease
• Chronic narcotic consumption
• Fibromyalgia
• Inability to provide consent

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1Z5, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mara Sobel, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Sobel, MD

CONTACT

416-586-4800; mara.sobel@sinaihealthsystem.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Core Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 24, 2018
• Study Start: August 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)